PDF Approved according to SOP 04.07.08 – Anl. A, Vers. 02 The Signature will not be printed! LAN User’s Manual ExA Accu-Chek® Spirit Combo Insulin pump 00_Cover_1+2_en-us.indd 1 03.06.2016 13:39:13 Kat.
Your insulin pump d f Menu key OK key Cartridge compartment with cartridge man_05504929001_H_en-us.indb 2 Adapter a Up key s Down key Luer-lock connector of the infusion set 01.06.
Pump details and accessories Battery key Battery cover Battery Infrared window (next to battery cover) Adapter Cartridge compartment Cartridge Piston rod man_05504929001_H_en-us.indb 1 End plate Cartridge plunger 01.06.
Overview of the ADVANCED user menu jj Press d to move forward jj Press d + a simultaneously to move backward jj Press f to select or save jj Press a to go up jj Press s to go down STOP RUN f BRP f = Basal Rate Profile 2–4 man_05504929001_H_en-us.indb 2 BRP 4 BRP 4 BRP 3 BRP 3 BRP 2 BRP 2 01.06.
Overview of the STANDARD and CUSTOM user menus Accessible menus in the CUSTOM user menu can be selected using the appropriate Accu-Chek PC software (sold separately). jj Press d to move forward jj Press d + a simultaneously to move backward jj Press f to select or save jj Press a for up jj Press s for down STOP RUN f f = not accessible in the STANDARD user menu man_05504929001_H_en-us.indb 3 01.06.
Dear user of the Accu-Chek Spirit Combo insulin pump, This User’s Manual is provided for you, as a person with diabetes, and for healthcare professionals. It contains all the necessary information for the safe and efficient use of your Accu-Chek Spirit Combo insulin pump. Regardless of your level of experience with pump therapy, please read this User’s Manual carefully before beginning insulin pump therapy.
About this User’s Manual To ensure the safe and convenient use of your new Accu-Chek Spirit Combo insulin pump, some information in this User’s Manual requires particular attention. This information is presented as “Warning”, “Caution” or “Note”. jj A “Warning” informs you about risks to your health. Neglecting this information may even lead to life-threatening situations in some cases. jj A “Caution” informs you about risks to your device.
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1 Understanding your new system 1.1 1.2 1.3 1.4 1.5 1.6 Overview Display and sounds Keys and key combinations Accessories and disposables Emergency kit General safety information 1 3 9 13 16 17 2 Getting started 19 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.
6 Using the Accu-Chek Spirit Combo insulin pump with the Meter 127 6.1 Meter 6.2 Switching Bluetooth ® ON and OFF 6.3 Pairing your pump with the Meter 6.4 Troubleshooting the Bluetooth ® connection 127 129 130 133 7 Care and Maintenance 137 7.1 7.2 7.3 7.4 7.5 7.6 7.7 Inspecting your pump Damage to your pump Your insulin pump and water Repair of your pump Maintaining your pump Storing your pump Disposing of your pump 137 139 140 142 143 144 144 8 Warnings and errors 145 8.1 8.2 8.3 8.
1 1 Understanding your new system 1.1 Overview Your Accu-Chek Spirit Combo insulin pump has many helpful features that help to ensure safe and efficient pump therapy. Note In this User’s Manual the term “Meter” always refers to your Accu-Chek diabetes management device (diabetes manager), which is compatible with your Accu-Chek Spirit Combo insulin pump.
STANDARD This is the most basic menu – designed for simplicity and comfort. ADVANCED This menu helps you to adjust your therapy to a wider range of situations. CUSTOM The CUSTOM menu enables you to fine-tune your pump according to your personal needs and skill level. See chapter 5 Personalizing your pump. Quick Bolus You can program a Quick Bolus without looking at the display screen and check that it is correctly programmed by counting the beeps and vibrations.
1 Reminder As well as warnings and errors, your pump can signal reminders. This works like an electronic alarm clock. Choice of batteries Your Accu-Chek Spirit Combo insulin pump can be powered by either disposable or rechargeable batteries. (If you decide to use rechargeable batteries, you will need a battery charger recommended by the battery manufacturer.) Key Lock The Key Lock feature allows you to lock all 4 keys on your pump to prevent functions from being activated accidentally.
1.2.1 Backlight 1.2.2 Rotating display The backlight helps you to read the information on the display in poorly-lit areas. You can turn on the backlight while in RUN or STOP mode, or when navigating through the menus, by pressing a. Your pump’s display can be rotated by 180 degrees. See section 5.6.4 Display orientation. Note that when you rotate the display, the s and a key functions will be reversed.
1 1.2.3 Display screens The screens displayed by your pump relate to one of the following modes: jj RUN jj STOP jj QUICK INFO The following screens are all accessed from the user menus (see section 5.2 Selecting a user menu): jj Information jj Function jj Set-up Note To save battery life, the screen of your Accu-Chek Spirit Combo insulin pump goes blank if you do not press any key for more than 20 seconds.
The RUN screen also displays reminder information (such as “cartridge low”) and special functions (such as Key Lock – locked or unlocked) in the form of symbols. (See Appendix F: Symbols) Note After you program or review information, the pump returns to the RUN screen. STOP screen The STOP screen is displayed when the pump is in STOP mode. This means that insulin is no longer being delivered to your body. The STOP screen shows the current time and date, and the STOP symbol.
1 By pressing f again you enter the BOLUS DATA function. You can view the last 30 boluses by pressing a or s. 1.2.4 Navigating through the screens The following procedure explains how to navigate through the screens. Think of these screens as menu choices. See section 1.2.3 Display screens. You can leave the QUICK INFO screen either pressing f again or pressing no key for 20 seconds.
You can move backward through the main menu screens by pressing the d key and a key simultaneously. In any submenu the same key combination will move you back to the main menu screen. Note Changes that you made in the submenu will not be saved. 1.2.5 Status messages and alarm signals Your Accu-Chek Spirit Combo insulin pump informs you of the status of your pump using audible beeps, vibrations and displayed messages. It is vital that you be able to hear and / or feel the beeps and vibrations.
1 To turn off the STOP warning, press either a or s for 3 seconds. You then hear a melody, confirming that the STOP warning has been turned off. If you press the key too briefly, the STOP warning will not be turned off. Note For your safety, the volume of the STOP warning cannot be changed. It is independent of the programmed beep volume. 1.3 Keys and key combinations You use the 4 keys on the Accu-Chek Spirit Combo insulin pump to program functions, access information, and set up the pump.
The following table lists the keys and their functions. Key Name Function Key Name Function d Menu jj Move through menus, function screens and information screens s Down f OK jj Select a menu jj Save changes and exit the function and information screens jj View the QUICK INFO screen a Up jj Move forward in the information screens jj Increase a setting jj Turn on the backlight jj Program a Quick Bolus jj Cancel a Quick Bolus jj Turn off the STOP warning (press and hold 3 sec.
1 1.3.1 Combining keys w You can obtain additional functions by pressing 2 keys simultaneously. In the following table, a plus symbol (+) indicates that both buttons must be pressed at the same time. Combination Function d+a jj Exits menus, function screens and information screens without saving your changes. jj Moves you to a previous menu. d+s jj Unlocks the keys. Press and hold both buttons until you hear 3 short beeps (RUN mode) or 3 long beeps (STOP mode).
1.3.2 Scrolling 1.3.3 Locking the keys To enter larger or smaller values, the a and s keys must sometimes be pressed several times until the desired value is shown, with each press of the key changing the figure by a small increment. However, you can also press and hold the key (scrolling function) to change the value faster. When programming boluses and hourly basal rates the increment of the value change increases if you keep the a or s key pressed.
1 1.4 Accessories and disposables w High-quality sterile disposables and accessories are a vital part of the Accu-Chek Spirit Combo insulin pump system, and help to ensure safe pump therapy. (For a list of accessories and disposables tested and found to be safe with the Accu-Chek Spirit Combo insulin pump, see Appendix C.) The infusion set is the applied part.
1.4.2 Adapter 1.4.3 Battery vents Your pump requires a 1.5 V AA alkaline (LR6) or lithium (FR6) battery that has a mimimum capacity of 2500 mAh. grip seal thread The adapter connects the cartridge to the infusion set, and also keeps the cartridge compartment watertight with 2 seals, one inside and one outside the adapter. It holds the cartridge in place and prevents the entry of air bubbles. The 2 small vents on the adapter allow air pressure to be equalized inside and outside the cartridge compartment.
1 c CAUTION Use of batteries other than those recommended may significantly reduce battery usage time. Such batteries may also leak and corrode the battery contacts in your pump. They could also lead to an electronic short circuit resulting in dangerous heat development. The use of batteries not supplied or recommended by Roche may void the warranty. Before inserting rechargeable batteries make sure that they are not damaged (e.g.
1.5 Emergency kit It is highly recommended to keep accessories and disposables with you in case of an emergency. This enables you to change these items if necessary. Consult the instructions for use coming with your medical devices (e.g. lancing device), accessories and disposables. w WARNING Make sure that you have an alternative therapy plan, provided by your healthcare professional. Use this plan whenever you need to interrupt pump therapy.
1 1.6 General safety information w WARNING Always make sure to accurately program your personal settings to avoid inappropriate insulin delivery. This phrase means that either too much or too little insulin is delivered. Too much insulin can lead to severe hypoglycemia. Too little insulin can lead to a life-threatening ketoacidosis. w c CAUTION If you should drop your pump, immediately inspect it carefully for damage.
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2 2 Getting started This chapter explains how to prepare your pump and begin insulin pump therapy. 2.1 Before you begin Successful insulin pump therapy requires you to check your blood glucose levels frequently. It is therefore recommended that you use an Accu-Chek blood glucose meter as often as directed by your doctor or healthcare team. Your Accu-Chek Spirit Combo insulin pump has been designed for use with the Meter.
Procedure for inserting and changing the battery 1. 2. Remove or disconnect your infusion set from the infusion site, to ensure that there is no risk of accidental insulin delivery. Press d to move to the STOP YOUR PUMP screen. Press f to select. Your pump is now in STOP mode and insulin delivery stops. 3. 4. Remove the battery cover. Use the battery key to turn the battery cover counter-clockwise. Make sure that the opening of the battery compartment and the seal are clean and undamaged.
2 5. 6. Use the battery key to fully tighten the battery cover. You can verify that the battery cover is correctly tightened by checking that it is in line with the pump casing. Do not over-tighten. Place the cover on the positive end and gently push the battery in, while turning the cover clockwise to partially tighten it. After inserting the battery, the pump begins its start-up process (see section below).
c CAUTION To prevent water from entering the pump casing, only insert or change the battery in a dry environment. Make sure that the battery cover seal is not worn or missing, and that the battery is correctly inserted. Note w If your pump was in RUN mode before you removed the battery, the error E8: POWER INTERRUPT will occur when the new battery is inserted. Press f twice to confirm and snooze the error. Check the time and date and correct them if necessary. Then put your pump into RUN mode.
2 2.3 Start-up process Your pump runs a start-up process when you insert a battery or when you change the cartridge. During this process, your pump performs a series of internal tests. When you … Then … change only the cartridge the start-up process begins at the SELF-TEST screen. w When you … Then … change the battery the whole start-up process is performed. WARNING Do not interrupt the start-up process by pressing keys or otherwise handling the insulin pump.
4. w The BEEP TEST screen appears and your pump beeps. Listen for the beeps. w WARNING If you cannot feel the vibrations, you may not be notified of changes within the pump in time to take action. If you do not feel the vibrations, stop using the pump and contact your Accu-Chek Customer Care. (See inside back cover) WARNING If you cannot hear the beeps from your Accu-Chek Spirit Combo insulin pump, you may not be notified of changes within the pump in time to take action.
2 8. 9. 10. The display turns black. Check that the display is completely black. If your pump detects a warning or an error during the start-up process, it signals the error or warning at this point. See section 8.3 List of errors. After the self-test, press a or s to select the type of battery you inserted. 11. The end of the start-up process is signalled by a melody, and the pump displays the STOP screen. The STOP warning occurs every minute.
2.4 Setting the time and date It is essential to set the time and date correctly, because basal rates and history information are stored on the basis of the time and date set in the pump. When you travel across time zones, and for the change to and from daylight savings time, make sure that the time and date are re-set correctly. You can choose between American or European / Military time.
2 Procedure for setting the time and date 1. 2. 3. Press d to move to the TIME AND DATE SETTINGS screen. The HOUR screen is displayed. Press d to move to the MINUTE screen. Press a or s to set the hour. Press a or s to set the minute. 4. 5. 6. Press d to move to the YEAR screen. Press d to move to the MONTH screen. Press d to move to the DAY screen. Press a or s to set the year. Press a or s to set the month. Press a or s to set the day. Press f to select. 27 man_05504929001_H_en-us.
7. 8. Press d to move to the TIME FORMAT screen. Press d to move to the DATE FORMAT screen. Press a or s to set the time format. Press a or s to set the date format. Press f to save and exit. 28 man_05504929001_H_en-us.indb 28 01.06.
2 2.5 Your basal rate profile For your safety and convenience during programming, your Accu-Chek Spirit Combo insulin pump switches to RUN or STOP screen if no key is pressed within 20 seconds. Any changes you have made before this “time-out” occurs will not be saved. Your Accu-Chek Spirit Combo insulin pump must be programmed with your personal settings before you begin pump therapy. Your doctor or healthcare team can help you to understand how to use the pump. Note 2.5.
Your basal rate profile should be reviewed: jj After any programming changes are made to your pump jj After a new battery is inserted jj After confirming the error E7: ELECTRONIC ERROR. Note Insulin delivery does not stop or pause during basal rate programming. Procedure for programming your basal rate profile 1. 2. 3. Press d to move to the BASAL RATE PROGRAMMING 1 (2, 3, 4 or 5 accordingly) screen. Press f to select. Press d to move to the first hour. The daily BASAL RATE TOTAL is displayed.
2 4. Note Press a or s or scroll to set the hourly basal rate given by your doctor or healthcare team. 6. Continue using d and a or s to set the hourly basal rates for the remaining hours. This allows you to program your individual basal rate profile on an hour-by-hour basis. Continue until all 24 hours are programmed. The increments shown depend on the programmed basal rate: it will be 0.01 U from 0.05 U to 1.00 U, 0.05 U from 1.00 U to 10.0 U and 0.1 U from 10.0 U to 25.0 U 5.
Copying an hourly basal rate 1. 2. Press d to move to the BASAL RATE PROGRAMMING 1 (2, 3, 4 or 5 accordingly) screen. Press f to select. 4. 5. If your basal rate is the same for multiple hours in a row, you can save time by copying an hourly basal rate to one or more hours. 3. The daily BASAL RATE TOTAL is displayed. If you want to copy the rate to multiple hours, press a and s repeatedly or press and hold a and s (scroll). Press d to move to the hourly basal rate you want to copy.
2 6. Note At any point in the programming of your basal rate, you have the following options to exit. If you want to … Then … Press f to confirm. Review the new daily BASAL RATE TOTAL. Press f to save and exit. save the changes jj Press f and check the new daily basal rate total. jj Press f again. Your pump returns to the RUN or STOP screen.
Selecting a basal rate profile 1. 2. Press d to move to the BASAL RATE SELECTION screen. Press f to select. When you have programmed more than one basal rate profile (ADVANCED or CUSTOM MENU), you can select the required profile. The SELECT PROFILE for the current basal rate profile is displayed. 3. Press a or s to select a basal rate profile. 4. Press f to select the displayed profile. The new basal rate profile is active immediately.
2 Note When you change your user menu for example from ADVANCED to STANDARD, your current basal rate profile may not appear. If the basal rate profile number(s) you want does not appear: jj Select the ADVANCED user menu, or jj Assign the basal rate profile to an available basal rate profile number A running Temporary Basal Rate increase or decrease stays active, even if you change the basal rate profile on your pump.
2.6 Connecting the cartridge, adapter and infusion set Before you change the cartridge, adapter or infusion set, check that your pump is in good working order. See section 7.1.1 Checklist. Insulin can flow uncontrolled from the cartridge or infusion set if the cartridge plunger and the piston rod are not properly connected and the pump is positioned at a higher level than the infusion site.
2 Procedure to connect the cartridge, adapter and infusion set 1. 2. 3. Remove the protective cap from the filled cartridge. (Do not touch the cartridge tip.) Push the adapter all the way onto the cartridge tip, until it stops. Carefully prepare a new Accu-Chek infusion set, following the instructions supplied for use. 4. Hold the adapter and twist the infusion set luer-lock connection by hand, clockwise into the adapter. Do not over-tighten.
2.7 Inserting the cartridge Have the following materials ready: j A filled Accu-Chek Spirit 3.15 ml cartridge system with a connected Accu-Chek Spirit Combo insulin pump adapter j A new Accu-Chek infusion set w WARNING Do not use your pump for the delivery of medication other than U100 rapid-acting insulin.
2 4. Hold the pump with the adapter facing the ground. Remove the cartridge, if necessary. Unscrew carefully. Do not pull the cartridge out until it is completely unscrewed. 7. The piston rod begins to return. Do not touch or otherwise disturb the piston rod while it is rewinding, as this could result in damage to your pump. 5. 6. Press d to move to the CARTRIDGE CHANGE screen. Make sure your infusion set is disconnected and the cartridge has been removed. Press f to select.
9. 10. see step 10 Hold your pump upright. Hold the new filled cartridge so that the connected adapter and infusion set points upward, parallel, and close to the cartridge compartment. see step 11 Make sure that the top edge of the threaded part of the adapter is level with the top of the cartridge compartment. 11. 12. Press a or s to move the piston rod forward until the end plate of the piston rod is level with the bottom of the cartridge plunger.
2 13. 14. Position your pump diagonally downwards (with the adapter pointing down). Insert the cartridge into the cartridge compartment. Do not insert the cartridge into your insulin pump without first connecting the infusion set tubing. If the tubing is not connected first, insulin may flow into the cartridge compartment, which may result in insulin entering your pump and causing damage to your pump. 15. Do not hold your pump upright when inserting the cartridge.
17. 18. 19. If the end plate of the piston rod is not correctly aligned with the cartridge plunger, remove the cartridge from the cartridge compartment and repeat steps 9 to 15. Check that the infusion set luer-lock connector is still correctly connected to the adapter. Tighten the infusion set clockwise by hand, until it sits tightly in the adapter. Press f after correctly inserting the cartridge. 20. See section 2.8 Priming the infusion set.
2 2.8 Priming the infusion set w WARNING Never prime an infusion set that is connected to your body as you risk uncontrolled insulin delivery into your body. Always follow the instructions for the infusion set you are using. The Accu-Chek Spirit Combo insulin pump stops priming at 25 units of insulin. If no insulin emerges from the needle or there are air bubbles in the tubing after priming, repeat the priming function until the infusion set is bubble-free and completely filled with insulin.
Procedure for priming the infusion set 1. 2. Press d to move to the STOP YOUR PUMP screen. The pump displays the STOP screen, and insulin delivery stops. 3. Prepare the tubing or cannula for priming according to the infusion set’s instructions for use. Press f to select. 4. 5. Press d to move to the INFUSION SET PRIMING screen. Make sure your infusion set is disconnected. Press f to select. The priming amount of 25 units of insulin is shown on the display.
2 7. The infusion set is properly primed when there are no air bubbles visible in the tubing and a drop of insulin has come out of the needle. When the priming process is complete, your pump returns to STOP. A count-up is shown on the display. Your pump stops priming after 25 units. You can stop the priming process at any time by pressing f. 45 man_05504929001_H_en-us.indb 45 01.06.
2.9 Positioning the infusion set Always follow the instructions given to you by your doctor or healthcare team and the instructions for the infusion set you are using. Have the following materials ready: j Your Accu-Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu-Chek infusion set Change your infusion set as frequently as recommended by the manufacturer. 2.9.
2 2.9.2 Inserting the cannula 1. 2. Make sure that your pump is properly connected (including cartridge, adapter and infusion set) and correctly programmed with your personal settings. Make sure your pump is in STOP mode. 3. 4. 5. Wash your hands thoroughly. Disinfect the infusion site and let it dry completely. Insert the cannula of your Accu-Chek infusion set according to the instructions. 47 man_05504929001_H_en-us.indb 47 01.06.
Note w If you use an infusion set with a soft cannula, you must proceed with a bolus to fill the air space in the cannula and headset, according to the instructions for the infusion set you are using. Failure to do so could result in missed insulin dosing. See section 4.2 Programming a Standard Bolus. If you have read and followed all instructions, cautions, warnings and notes found in this chapter, you should now be ready to deliver insulin to your body using your Accu-Chek Spirit Combo insulin pump.
2 2.9.3 Connecting the insulin pump w WARNING Pay attention to the tubing of the infusion set connected to your body. There is a risk of strangulation if the tubing becomes wrapped around your neck. In case of doubt, use the shortest tubing length to minimise the risk of strangulation. 1. Attach the infusion set to the insulin pump and start insulin delivery. See section 2.10 Starting insulin delivery. 49 man_05504929001_H_en-us.indb 49 01.06.
2.10 Starting insulin delivery Procedure for starting insulin delivery 1. 2. 3. Your pump is in STOP mode. Press d to move to the START YOUR PUMP screen. Press f to select. Your pump shows the RUN screen. Insulin delivery begins within 3 minutes. 50 man_05504929001_H_en-us.indb 50 01.06.
2 2.11 Stopping insulin delivery For your safety, you must only perform certain functions and actions when the pump is in STOP mode. These functions and actions include: jj changing the cartridge jj connecting and disconnecting the adapter and / or infusion set jj priming the infusion set jj data transfer c CAUTION When your Accu-Chek Spirit Combo insulin pump is in STOP mode, no insulin is delivered to your body. You must put your pump into RUN mode to continue insulin delivery.
2.12 General safety information STOP warning The STOP warning is triggered when your pump switches from RUN mode to STOP mode, or when a battery is inserted. The pump emits 2 short beeps and vibrates once every minute. This warns you that insulin delivery has been interrupted. To turn off the STOP warning, press either a or s for 3 seconds. You then hear a melody and /or feel a vibration, confirming that the STOP warning has been turned off.
2 w WARNING A lways check your personal settings before using your new pump, in order to avoid incorrect insulin delivery. Record your personal settings from your current insulin pump, and ensure that they are correctly programmed into your new Accu-Chek Spirit Combo insulin pump. Incorrect programming of your pump may cause incorrect insulin delivery. Do not use the pump without knowing your personal settings.
Note Your pump cannot detect infusion set leakage. If you detect any loss of insulin and all parts are correctly tightened, immediately replace the leaking component. Because insulin delivery has been interrupted, check your blood glucose level and take appropriate action according to your doctor’s or healthcare team’s instructions. Note If the battery is too low, the start-up process may not be able to complete.
3 3 Using your pump in daily life This chapter provides important guidelines on how to use your pump safely from day to day. 3.1.1 When not to wear your pump Electromagnetic fields and hazardous areas 3.1 Wearing your pump Attach your pump safely to your body or clothes to prevent damage. You can use one of our special carrying systems that enable you to carry your pump on or under your clothes. Wear your pump under your clothes or directly on your body to protect it from hot, cold or wet weather.
Your pump has been tested against, and complies with, the regulations on electromagnetic interference. Security systems in airports and anti-theft monitoring devices, such as those in department stores, should not normally affect the functioning of your pump. Because there are so many devices, such as cellular phones, that emit electromagnetic radiation, the effect of such devices on your pump cannot be ruled out.
3 Note Rapid and extreme changes in air pressure, for example in an air plane that is taking off or when practicing sports like hang-gliding, can influence insulin delivery, especially if there are air bubbles in the cartridge or tubing. This also applies to rapid and extreme changes in temperature; for example, when leaving a heated room and going outside in cold weather.
3.2 I nterruption of insulin pump therapy Consult with your doctor or healthcare team about when and for how long your insulin pump therapy can be interrupted. Measure your blood glucose level regularly during any insulin delivery interruption. Use a syringe or insulin pen to inject insulin according to the instructions of your doctor or healthcare team. w WARNING Because only rapid-acting insulin is used for insulin pump therapy, only a small amount of insulin is stored in the body.
3 3.2.1 Short interruptions 1. 2. Press d to move to the STOP YOUR PUMP screen. Press f to put your pump in STOP mode. Resuming insulin delivery 1. Reconnect your infusion set or insert a new one and put your pump into RUN mode. 3. Remove the infusion set or, when using a disconnectable infusion set, disconnect the transfer set from the headset and use the protective covers that came with it. Where appropriate, attach a new Accu-Chek infusion set. (See section 3.4 Changing the infusion set).
3.2.2 Long interruptions 1. 2. When you need to interrupt your pump therapy for more than one day, use the following procedure. Put your pump into STOP mode. Remove the cartridge, adapter, and infusion set. 3. Remove the battery and reinsert the battery cover. Store your pump properly. See section 7.6 Storing your pump. 60 man_05504929001_H_en-us.indb 60 01.06.
3 3.3 Your insulin pump and water c CAUTION Before any contact with water, disconnect and take off your Accu-Chek Spirit Combo insulin pump. Check your pump daily to ensure that it is not chipped, cracked or damaged in any way, and that the battery cover and the adapter are correctly closed. Otherwise water, dust, insulin, or other substances may enter your pump and lead to malfunction. 3.3.
What to do after any water contact Put your pump into STOP mode, disconnect the pump from your body, and inspect it. Use a soft cloth to dry the outside of the pump, and check the battery compartment and the cartridge compartment for water. If the battery compartment or cartridge compartment are wet, turn your pump upside down to let the water run out and leave it to dry. Do not use warm air such as a hair dryer to dry the pump, as this could damage the pump’s housing.
3 3.4 Changing the infusion set When you change the infusion set, keep the following information in mind: jj Infusion sets are sterile products intended for single use only. Sterility is guaranteed for unopened packaging up to the indicated expiry date. Do not use sterile products if the package is damaged. jj Correctly tighten the infusion set onto the adapter to avoid leakage. Turn the infusion set luer-lock connector until it stops.
Procedure for changing the infusion set Have the following materials ready: j Your Accu-Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu-Chek infusion set 1. 2. Make sure your pump is in STOP mode. Wash your hands thoroughly. 3. Disconnect the transfer set from the headset. 4. 5. Remove the infusion set from the adapter and dispose of it correctly. Tip: The battery key has a notch that fits all Accu-Chek infusion set luer-lock connectors.
3 6. 7. 8. Remove the used infusion headset and dispose of it correctly. Carefully prepare a new Accu-Chek infusion set for use. Screw the Accu-Chek infusion set clockwise into the adapter. Carefully tighten the luer-lock connector by hand. 9. 10. 11. Prime the infusion set following the instructions found in section 2.8 Priming the infusion set. Put the pump in RUN mode. See section 2.10 Starting insulin delivery.
Note w If you use an infusion set with a soft cannula, you must begin with a bolus to fill the air space in the cannula and headset, according to the instructions for use for the infusion set you are using. Failure to do so could result in inadequate insulin dosing. See section 4.2 Programming a Standard Bolus. WARNING Inspect your infusion site at least twice each day for irritation or infection. Signs of infection may include, but are not limited to: pain, lumps, redness, heat, or discharge.
3 3.5 Changing the cartridge and infusion set Have the following materials ready: j Your Accu-Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu-Chek infusion set j A filled Accu-Chek Spirit 3.15 ml cartridge system j A new adapter (this must be changed at least every 2 months) Procedure for changing the cartridge and infusion set 1. 2. 3. Wash your hands thoroughly. Remove the transfer set from the headset. Make sure your pump is in STOP mode. 67 man_05504929001_H_en-us.
4. 5. Hold your Accu-Chek Spirit Combo insulin pump with the adapter pointing downward. Remove the adapter and cartridge from your pump by unscrewing the adapter from the pump casing. 6. Remove the transfer set from the adapter and dispose of it correctly. Note Pulling the adapter from the pump casing without completely unscrewing it may result in the plunger staying attached to the piston rod. If this should happen, please call your Accu-Chek Customer Care (see inside back cover). 7.
3 8. 9. 10. Hold the adapter to the light to check for signs of wear or dirt (especially on the seals inside and outside of the adapter). If necessary, clean the adapter using water and dry it. If it shows signs of wear or dirt, replace it immediately. Insert a new cartridge and a new infusion set. See section 2.7 Inserting the cartridge. 69 man_05504929001_H_en-us.indb 69 01.06.
3.6 General safety information w WARNING Always carry spare sterile products and accessories (infusion set, insulin cartridge, batteries), an insulin pen/syringe, and insulin. Without insulin, hyperglycemia or diabetic ketoacidosis may develop and may require in-patient hospital treatment. c CAUTION Note Check the amount of insulin remaining in the cartridge at least once a day. Press f from the RUN or STOP screen to display the remaining cartridge content in units.
4 4 Boluses and Temporary Basal Rates 4.1 Understanding boluses A bolus is the amount of insulin delivered (in addition to the basal rate) to cover the intake of food and to correct high blood glucose levels. The bolus type and amount is determined by your doctor or healthcare team’s guidelines, your blood glucose level, your food intake, your health condition, and your activity level. Discuss the timing, the amount and type of bolus you need with your doctor or healthcare team.
4.2 Programming a Standard Bolus There are 2 ways to program a Standard Bolus: Quick Bolus Using a and s on your insulin pump, with bolus increments determined by the user Using Standard Bolus menu Using d and f to enter the menu and then a and s to program the amount The bolus amount per delivery is limited to 25 units. After you program a Standard Bolus, there is a delay of 5 seconds before bolus delivery starts. This delay allows you to cancel the bolus by pressing the a or s key if desired.
4 4.2.1 Programming a Quick Bolus The following process uses only the a and s keys. You can start with either key. The recommended steps below are those described for the Down key s in step 1 and the Up key a in Step 2. For the alternative step, you can use the Up key in step 1 and the Down key in step 2. Because your pump beeps and vibrates to guide you through the programming steps, you can program the Quick Bolus without looking at the pump screen.
4. 5. 5 seconds after the last press of a, your pump confirms the total bolus amount with one beep and vibration for each bolus increment programmed. w The Standard Bolus symbol blinks for 5 seconds (the bolus delivery start delay). 6. After the bolus delivery start delay, the pump beeps 3 times and vibrates and then begins to deliver the total bolus amount programmed. A countdown of the remaining bolus amount appears on the display.
4 4.2.2 Cancelling a Quick Bolus During programming (the bolus amount blinks) Press the s or a key you used to enter the Quick Bolus programming option. This will reset the bolus amount to 0.0 units. You hear a melody. If no new bolus is programmed, your pump returns to the RUN screen and beeps 3 times and vibrates after 5 seconds. No bolus is delivered. During confirmation (when the beeps and vibrations occur), or During start delay (Standard Bolus symbol blinks) Press s or a. You hear a melody.
4.2.3 Programming a Standard Bolus using Standard bolus menu 1. Independent of the bolus increment setting, the bolus increments for the menu-guided Standard Bolus are fixed at 0.1 unit. You can program this bolus in the STANDARD BOLUS screen by holding the a or s key (scrolling) until the bolus amount is displayed. Press d to move to the STANDARD BOLUS screen. 2. 3. 4. Press f to select. The BOLUS AMOUNT screen appears. Press or scroll a to increase or s to decrease the bolus amount.
4 After this bolus delivery start delay, your pump beeps 3 times and vibrates and begins to deliver the total bolus amount programmed. The countdown of the remaining bolus amount appears on the display. 4.2.4 Cancelling a Standard Bolus During programming (the bolus amount blinks) You have 3 options for cancelling during programming: j If you do not press any key for 20 seconds after programming the bolus amount, your pump returns to the RUN screen.
Cancellation during the start delay and during the bolus delivery will cause a WARNING W8: BOLUS CANCELLED. Press f twice to confirm and snooze the warning. See chapter 8 Warnings and errors. Note Make sure that the cancellation was deliberate and program a new bolus, if needed. 4.3 Programming an Extended Bolus The Extended Bolus option enables you to program a bolus to be delivered over a period of time.
4 Tip: You can program a Standard or Quick Bolus while an Extended Bolus is ongoing. If you cancel the Standard Bolus, the Extended Bolus continues to run. During the delivery of an Extended Bolus, the programming of another Extended Bolus or a Multiwave Bolus is blocked. If you try to do this, you will receive the error message: “Bolus currently running”. If you want to program a different Extended Bolus, put the pump in STOP mode to cancel the current bolus.
4. 5. Tip: Press d to switch between programming the bolus amount and bolus duration. Press d to move to the BOLUS DURATION screen. Press f to confirm the bolus amount and duration. The pump returns to the RUN screen. The bolus delivery begins within the next 3 minutes. Press a to increase or s to decrease the bolus duration.
4 4.3.1 Cancelling an Extended Bolus During programming (the bolus amount or bolus duration blinks) You can either: j wait for your pump to return to the RUN screen. j press d and a simultaneously to exit the Function screen. j set the bolus amount to 0.0 units and press f. No bolus is delivered. During bolus delivery j If the Extended Bolus delivery has begun, it can be cancelled by putting your pump into STOP mode. This cancels the bolus delivery and the warning W8: BOLUS CANCELLED is displayed.
Note If a Temporary Basal Rate is active at the same time, it is also cancelled when your pump is put into STOP mode. The warning W8: BOLUS CANCELLED and the warning W6: TBR CANCELLED are displayed. Press f twice to confirm and turn off the first warning. The second alert appears on the display. Press f twice to confirm and turn off the second warning. Both alerts are recorded in the warnings history. See chapter 8 Warning W6: TBR CANCELLED and Warning W8: BOLUS CANCELLED.
4 4.4 Programming a Multiwave Bolus The Multiwave Bolus option is available in the ADVANCED user menu. It is designed to better simulate the body’s insulin delivery, and combines an immediate bolus delivery followed by an Extended Bolus delivery. This option can be helpful when you have meals that include both rapidly and slowly absorbed carbohydrates. The duration of bolus delivery can be programmed in 15-minute intervals for up to 12 hours.
Procedure for programming a Multiwave Bolus 1. 2. 3. Press d to move to the Multiwave Bolus screen. Press f to select. The BOLUS AMOUNT screen appears. Press a or s to increase or decrease the total bolus amount. Note The first time you press a, the bolus duration of the last Multiwave Bolus and a default immediate bolus amount appear. The latter increases or decreases proportionally as you increase or decrease the total bolus amount. 4. 5. Press d to move to the IMMEDIATE BOLUS screen.
4 6. 7. Check the total and immediate bolus amounts and the Extended Bolus duration programmed on the screens. Press f to confirm both bolus amounts and the bolus duration. The Multiwave Bolus symbol blinks for 5 seconds (bolus delivery start delay). Tip: Press d to loop between programming the total BOLUS AMOUNT, IMMEDIATE BOLUS and BOLUS DURATION. 8. The pump beeps 3 times and vibrates. The immediate bolus delivery begins. The countdown of the remaining bolus continues to appear on the display.
4.4.1 Cancelling a Multiwave Bolus During programming (the bolus amount blinks) There are 3 ways to cancel a Multiwave Bolus during programming: j Do not press any key for 20 seconds. The pump returns to the RUN screen. j Return to the Multiwave Bolus screen by pressing d + a simultaneously. j Set the total bolus amount to 0.0 units and press f. No bolus is delivered. During the start delay (Multiwave symbol blinks) j Press d + a, s or a. The pump beeps and vibrates.
4 Note If a Temporary Basal Rate is active at the same time, it is also cancelled when your pump is put in STOP mode. The warning W8: BOLUS CANCELLED and the warning W6: TBR CANCELLED are displayed. Press f twice to confirm and turn off the first warning. The second warning appears on the display. Press f twice to confirm and turn off the second warning. Both warnings are recorded in the alarm history. See chapter 8 Warning W6: TBR CANCELLED and Warning W8: BOLUS CANCELLED.
Note A running Temporary Basal Rate increase or decrease remains active, even if you have changed the basal rate profile. You can only program a Temporary Basal Rate when your pump is in RUN mode. Procedure for programming a Temporary Basal Rate 1. 2. Press d to move to the TEMPORARY BASAL RATE (TBR) screen. Press f to select. The TBR PERCENTAGE screen appears. Note If no Temporary Basal Rate is currently active, the percentage is set to 100 %.
4 3. Press a or s to increase or decrease the basal rate. 4. Tip: When you increase (or decrease) the Temporary Basal Rate, the duration of your previous Temporary Basal Rate increase (or decrease) appears. However, when you use your pump for the first time, a default value appears. Press d to move to the TBR DURATION screen. Press a or s to correct and set the duration. 5. Tip: You can switch between programming the basal rate percentage and duration by pressing d.
Note During Temporary Basal Rate delivery, the increase or decrease in percentage, the increased or decreased hourly basal rate (hourly basal rate plus TBR percentage), and the remaining time are displayed in the RUN screen. An arrow pointing upward symbolizes a Temporary Basal Rate increase; an arrow pointing downward symbolizes a Temporary Basal Rate decrease.
4 4.5.1 Cancelling a Temporary Basal Rate During programming There are 3 ways to cancel a Temporary Basal Rate during programming: j Do not press any key for 20 seconds. The pump returns to the RUN screen. j E xit the Temporary Basal Rate (TBR) screen by pressing d + a simultaneously. j Set the TBR percentage to 100 %. Press f to save and exit. Pump continues to deliver normal basal rate.
4.6 General safety information Note If an Extended Bolus or a Multiwave Bolus is active at the same time, it is also cancelled when your pump is put into STOP mode. The warning W8: BOLUS CANCELLED and the warning W6: TBR CANCELLED are displayed. Press f twice to confirm and turn off the first alert. The second alert appears on the display. Press f twice to confirm and turn off the second alert. Both alerts are recorded in the alarm history.
5 5 Personalizing your pump This chapter explains how to use the available menu options, and to personalize your pump to match your level of experience with insulin pump therapy. 5.1 Introduction Using the 4 keys on the pump, and their combinations, you can access the menu options and their relevant screens. This enables you to, for example: jj Program the pump jj Perform a function jj Change a setting jj Store information Note 5.1.
STANDARD This menu provides all the basic functions you need for successful pump therapy. If you are new to pump therapy, we recommend that you start with this menu. As you become more experienced, you may wish to change to the ADVANCED user menu. ADVANCED This menu provides the complete range of the Accu-Chek Spirit Combo insulin pump functions. It includes all the functions from the STANDARD user menu, plus a wide range of functions for the more experienced user.
5 5.2 Selecting a user menu Note For guidance in choosing the most suitable user menu, see section 5.1.1 User menus. If you are still not sure which menu to choose, discuss this with your doctor or healthcare team. Procedure for selecting a user menu 1. 2. 3. Press d to move to the MENU SETTINGS screen. The SELECT USER MENU screen is displayed. Press f to confirm. Press f to select. Press a or s to select a user menu.
4. 5. … if the previous basal rate profile is not available from the selected user menu, dashes appear instead. Press a or s to select a basal rate profile, if required. Check the (new) basal rate profile and its daily insulin total. Press f to save and exit. The new user menu and basal rate profile are active immediately. c CAUTION A running increased or decreased Temporary Basal Rate will remain active, even if you change the basal rate profile.
5 5.3 STANDARD user menu The following is a list of menu options from the STANDARD user menu. To view the order in which they appear on the display, refer to the menu diagram below: jj Press d to move forward jj Press d + a simultaneously to move backward STOP RUN f f 97 man_05504929001_H_en-us.indb 97 01.06.
Some of the functions have already been described elsewhere in this User’s Manual, as listed below. The remaining functions are described following the list. QUICK BOLUS jj See section 4.2.1 Programming a Quick Bolus. STANDARD BOLUS jj See section 4.2 Programming a Standard Bolus. TIME AND DATE SETTINGS jj See section 2.4 Setting the time and date. BASAL RATE PROGRAMMING jj See section 2.5.1 Programming your basal rate profile. CARTRIDGE CHANGE jj See section 2.7 Inserting the cartridge.
5 5.4 Viewing your pump data The memory of your Accu-Chek Spirit Combo insulin pump stores all the events (warnings and errors, programming operations and insulin delivery records), up to 4500 events. This data corresponds to about the last 90 days of use, and can be accessed on a personal computer using the Accu-Chek software products.
5.4.1 Viewing your bolus history The BOLUS DATA screen allows you to view up to the last 30 bolus deliveries, starting with the most recent entry.
5 5.4.2 Viewing the error and warning history The alarm data menu allows you to view up to the last 30 warnings and errors, starting with the most recent entry. Each alarm data screen displays: jj Number and type of the warning or error (for example, W6) jj warning or error (for example, TBR CANCELLED) jj Time jj Date jj Entry number (01 is the most recent) of total entries (example 01/30) of a warning or error Procedure for viewing the alarm history 1. 2. 3. Press d to move to the MY DATA screen.
5.4.3 Viewing the history of daily insulin totals This function allows you to view up to the last 30 daily totals of insulin delivered (from midnight to midnight; including basal rate plus boluses), starting with the most recent entry. Each screen displays: jj Daily total of insulin delivered jj Date jj Entry number (01 is the most recent) of total entries (example 01/04) of a daily insulin total Procedure for viewing the daily insulin totals 1. 2. 3. Press d to move to the MY DATA screen.
5 5.4.4 Viewing the Temporary Basal Rate history This option allows you to view up to the last 30 Temporary Basal Rate (TBR) increases or decreases, starting with the most recent entry. Each TBR DATA screen displays: jj TBR increase or decrease in percentage jj TBR duration jj Time jj Date jj Entry number (01 is the most recent) of total entries (example 01/30) of a delivered Temporary Basal Rate Procedure for viewing the Temporary Basal Rate history 1. 2. 3. Press d to move to the MY DATA screen.
5.4.5 Viewing the time remaining (pump timer) For loan pumps and “Backup” pumps, a pump timer limits the operating time. When you begin using the pump, the timer starts the countdown of the number of remaining days. symbol appears in the RUN screen or STOP screen. When the timer expires, an Error occurs, and your pump goes into STOP mode. It can no longer be put into RUN mode. See chapter 8 Warning W5: PUMP TIMER, Warning W9: LOANTIME WARNING and Error E5: END OF OPERATION.
5 5.5 Transferring your data to a computer The built-in infrared interface on the bottom of your Accu-Chek Spirit Combo insulin pump enables you to transfer data between your pump and a PC. information management products (for details see the user information provided with the software). For availability of the appropriate software see Appendix C.
4. Set up your pump with a cartridge, adapter, and a new infusion set, and put it in RUN mode if necessary. Note When the data transfer is complete, press f to return to the STOP screen. Your pump will return to STOP mode 15 minutes after the last data transfer when the DATA TRANSFER screen is selected. You can press d + a twice simultaneously to exit while data is being transferred. The data transfer is interrupted, and the error E12: DATA INTERRUPTED occurs. See chapter 8.
5 5.6 Pump settings 5.6.1 Turning Key Lock on and off These settings relate to the practical use of the pump. For settings relating to your therapy, see 5.10 Therapy settings later in this chapter. The Key Lock function allows you to lock the 4 keys of your Accu-Chek Spirit Combo insulin pump. This is an important safety measure that prevents you from accidentally activating functions, for example while sleeping or during contact sports.
Procedure for unlocking the Key Lock If you press any key while the screen is blank, the Key Lock symbol indicates that the keys are locked. Note The Key Lock remains unlocked during fast bolus delivery of Standard or Multiwave Bolus. 1. 2. 3 seconds to confirm that the Key Lock is unlocked. From the blank screen, press and hold d + s for 3 seconds. You hear 3 beeps in RUN or STOP mode when you press the keys and again after The Key Lock remains unlocked during the programming of the pump.
5 5.6.2 Adjusting the sound volume Your pump emits different acoustic signals in different handling situations to facilitate handling e.g. for blind or partially-sighted users. For details on the meaning of the sound patterns, see the Appendix “Beeps and melodies”. You can adjust the volume of the beeps according to your personal preference. There are 5 volume levels available: off, low, medium, high and maximum.
5.6.3 Changing signal settings Beep only The Accu-Chek Spirit Combo insulin pump enables you to choose how you want your pump to alert you when a warning or error occurs. You have 3 options: Vibrate only Beep and vibrate For your safety, if you do not respond to the vibration, the pump starts beeping after one minute. Procedure for changing the signal settings 1. 2. Press d to move to the PUMP SETTINGS screen. Press d to move to the SIGNAL SETTINGS screen. Press f to select.
5 5.6.4 Display orientation Note Your pump allows you to turn the display by 180°, so that you can view it more easily, depending on how you are wearing the pump. If you turn the display orientation of your pump by 180°, the functions of the a and s keys are also reversed. The functions of the d and f keys remains the same, whichever screen orientation you choose. Procedure for setting the display orientation 1. 2. 3. Press d to move to the ORIENTATION screen.
5.6.5 Setting the display contrast Your pump allows you to adjust the display contrast to suit your preferences. Procedure for setting the display contrast 1. 2. Press d to move to the PUMP SETTINGS screen. Press d to move to the DISPLAY CONTRAST screen. Press f to select. Press a or s to select the desired contrast level. 112 man_05504929001_H_en-us.indb 112 Press f to save and exit. 01.06.
5 5.6.6 Selecting the language Your pump can display the information in several languages. You can chose the language according to your preferences. Procedure for setting the language 1. 2. Press d to move to the PUMP SETTINGS screen. Press d to move to the LANGUAGE screen. Press f to select. Press a or s to select a language. Press f to save and exit. 113 man_05504929001_H_en-us.indb 113 01.06.
5.7 ADVANCED user menu The following is a list of additional menu options available in the ADVANCED user menu. To view the order in which they appear on the display, refer to the menu diagram below: jj Press d to move forward jj Press d + a simultaneously to move backward BRP STOP RUN = Basal Rate profile 2–4 f 114 man_05504929001_H_en-us.indb 114 f BRP 4 BRP 4 BRP 3 BRP 3 BRP 2 BRP 2 01.06.
5 5.8 Basal rate profiles Note The ADVANCED user menu contains all the options from the STANDARD user menu. Some of the functions are described elsewhere in this User’s Manual, as listed below. The remaining functions are described in this chapter following the list. MULTIWAVE BOLUS jj See section 4.4 Programming a Multiwave Bolus. Your pump has 5 different basal rate profiles to match your changing insulin needs (for example, Monday to Friday or Exercise Day or Sleeping Late Day).
Procedure for Programming additional basal rate profiles 1. 2. Press d to move to the BASAL RATE PROGRAMMING (1, 2, 3, 4, 5) screen you wish to program. The hourly basal rates for each additional basal rate profile are set in the same way as for basal rate profile 1. See section 2.5.1 Programming your basal rate profile. Press f to select. Note Only basal rate profiles that are accessible in your current user menu are available.
5 5.8.2 Selecting a basal rate profile 1. 2. Press d to move to the BASAL RATE SELECTION screen. Press a or s to select a basal rate profile. The selected basal rate profile and its daily insulin total appear. Procedure for selecting a basal rate profile Press f to enter. Press f to select. The new basal rate profile is active immediately. Note Only basal rate profiles that are accessible in your current user menu are available.
5.9 Setting a reminder You can set both single and multiple reminders on your pump. Multiple reminders are repeated at a set time every day. You can use this feature to remind you, for example, when you need to test your blood glucose. Procedure for setting single or multiple reminders 1. 2. 3. Press d to move to the REMINDER SETTINGS screen. Press f to select. The current REMINDER status and alarm time appear. Press a or s to change the REMINDER setting to OFF, ONCE or EVERY DAY.
5 4. 5. Press d to move to the HOUR screen. Press d to move to the MINUTE screen. Press a or s to set the hour. Press a or s to set the minute. Press f to save and exit. Turning off the reminder When the reminder sounds, the reminder screen is displayed. Press f twice to snooze and confirm and return to RUN or STOP mode (See also section 8.4 Reminder R1). 119 man_05504929001_H_en-us.indb 119 01.06.
5.10 Therapy settings These settings relate to the therapeutic use of the pump. For settings relating to the practical use of the pump, see pump settings earlier in this chapter. your Accu-Chek Spirit Combo insulin pump is adjustable. It is initially set to 0.5 units per key-press, but it can be changed to 0.1, 0.2, 0.5, 1.0 or 2.0 units. w 5.10.
5 5.10.2 Adjusting the prime amount The prime amount needed to fill an infusion set depends on the length of the infusion set tubing. The shorter your infusion set tubing, the less insulin will be required to prime the infusion set. The default setting for the prime amount is 25 units of insulin. Note The amount of insulin used for the priming is not added to the history of daily insulin totals. Procedure for adjusting the prime amount 1. 2. Press d to move to the THERAPY SETTINGS screen.
5.10.3 Locking basal rate profiles Your Accu-Chek Spirit Combo insulin pump allows you to adapt your hourly basal rate profile as needed. You can then lock your basal rate profiles to provide additional protection against accidentally changing a basal rate during normal operation. If the basal rate lock is set to ON, programming of the basal rate profiles 1, 2, 3, 4 and 5 is blocked.
5 5.10.4 Automatic Off Automatic Off is a safety feature that stops insulin delivery and triggers error E3: AUTOMATIC OFF if no keys are pressed within a programmed time period in RUN mode. This feature can either be set to OFF or programmed up to 24 hours in 1-hour intervals. The factory setting is OFF. Discuss using the Automatic off function with your doctor or healthcare team. Procedure for using Automatic Off 1. 2. 3. Press d to move to the THERAPY SETTINGS screen.
5.11 CUSTOM user menu The CUSTOM user menu is designed to adapt your pump to your special requirements and preferences. It allows you or your doctor or healthcare team to display or hide screens and thereby customize the individual user menus. jj Press d to move forward jj Press d + a simultaneously to move backward STOP RUN f f 124 man_05504929001_H_en-us.indb 124 01.06.
5 Note By default, the CUSTOM user menu contains all of the functions available except the following: jj Multiwave Bolus jj Basal rate profiles 3, 4 and 5 jj Therapy Settings To change the CUSTOM user menu, you, your doctor, or your healthcare team must use the appropriate Accu-Chek PC software. 125 man_05504929001_H_en-us.indb 125 01.06.
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6 6 Using the Accu-Chek Spirit Combo insulin pump with the Meter This chapter describes how the Accu-Chek Spirit Combo insulin pump works with the Meter, and explains how to pair the 2 devices using Bluetooth ® wireless technology. Note In this User’s Manual the term “Meter” always refers to your Accu-Chek diabetes management device (diabetes manager), which is compatible with your Accu-Chek Spirit Combo insulin pump.
6.1.1 Tasks that must be performed on the pump The following tasks cannot be performed remotely using the Meter: jj Changing the cartridge jj Priming the infusion set jj Data transfer jj Bluetooth ® settings jj Display settings All the other functions available on the Accu-Chek Spirit Combo insulin pump can be performed using the Meter. Before using your pump together with the Meter you must read the documentation (User’s Manual) provided with this product. 128 man_05504929001_H_en-us.indb 128 01.06.
6 6.2 Switching Bluetooth ® ON and OFF w WARNING You must ensure that Bluetooth ® is switched off on both devices before boarding an aircraft, as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft. To prolong the battery life and avoid accidental changes on your pump, you should switch off Bluetooth ® wireless technology, if the Meter is lost, stolen or, you plan not to carry it with you for a longer period of time.
6.3 P airing your pump with the Meter Your Accu-Chek Spirit Combo insulin pump and your Meter will already have been paired by default. If you need to replace one of the devices for any reason you need to redo the pairing. When pairing your Accu-Chek Spirit Combo insulin pump with the Meter, place both devices on a table or desk, so that you can see the displays of both devices clearly.
6 Note When Bluetooth ® is turned off, you cannot access the Paired Device menu. 4. Pump screen If the pump screen indicates that no paired device is available, turn on the Meter in pairing mode by holding down * and simultaneously pressing +. Meter screen 5. 6. The pump begins searching and detects the Meter, displaying its serial number (This process may take several minutes). Pump screen Press the d key on the pump to see the ADD DEVICE screen, and press f to initiate pairing.
7. 8. Pump screen The pump begins the pairing process and shows a 10-digit code. Enter the code on the Meter display, using =, x and z and then = to move to the next digit. Confirm the complete code with .. Meter screen After the pairing is completed press + to turn off the Meter. Meter screen 9. 10. The pump now shows the DEVICE PAIRED screen. Press f to confirm the pairing. The pump displays the PAIRED DEVICE screen. You can return to the RUN screen by pressing f.
6 6.4 Troubleshooting the Bluetooth ® connection In case of problems with the Bluetooth ® connection or after the appearance of the warning W10: BLUETOOTH FAULT, you have to repeat the pairing procedure described in section 6.3 Pairing your pump with the Meter. Since only one Meter at a time can be paired with your pump, you must delete the pairing before you can pair your pump with a new Meter. 1. 2. 3. Press d to move to the BLUETOOTH SETTINGS screen. Press f to enter the BLUETOOTH ON / OFF screen.
4. Press d to move to the DELETE DEVICE screen. Press f once to delete the pairing and a second time to confirm. 6.4.1 Handling warnings and errors The Accu-Chek Spirit Combo insulin pump and Meter behave in the following ways when warnings and errors occur. jj If both devices are switched on and paired you can enter the Meter’s pump menu and snooze and confirm the warning or error through the Meter.
6 6.4.2 Use in aircraft w WARNING You must ensure that Bluetooth ® is switched off on both devices before boarding an aircraft, as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft. 135 man_05504929001_H_en-us.indb 135 01.06.
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7 7 Care and Maintenance This chapter explains how to take care of your pump and keep it properly maintained. c CAUTION Do not perform any servicing or repair on your Accu-Chek Spirit Combo insulin pump as this may void the guarantee. For further information, contact your Accu-Chek Customer Care (see inside back cover). 7.1 Inspecting your pump Your pump must be properly maintained to guarantee accurate insulin delivery.
7.1.1 Checklist Check your pump daily, and make sure that: jj The pump casing, the display, and the cartridge are not chipped or cracked and that the display does not show incomplete or abnormal letters or symbols. jj You carefully inspect the cartridge. Make sure that the actual amount of insulin in the cartridge equals the displayed cartridge amount on the QUICK INFO screen. jj You inspect all parts of your pump and infusion set regularly during the day and before you go to sleep.
7 7.2 Damage to your pump 7.2.1 What to do if you drop your pump If the pump is dropped it could be damaged, as well as the seal that protects it against water. Use the specially designed pump carrying system to help avoid dropping your pump. See Roche Diabetes Care, Inc. sterile products and accessories catalogs and brochures for more information, or contact your Accu-Chek Customer Care (details on inside back cover).
7.3 Your insulin pump and water c CAUTION Immediately inspect your pump if it is dropped. Do not use your Accu-Chek Spirit Combo insulin pump if chips, cracks or other damages are visible. Otherwise water, dust, insulin or other foreign substances may enter your pump and could result in a malfunction. If you have questions or are not sure whether your pump has been damaged, contact your Accu-Chek Customer Care (details on inside back cover). c CAUTION Avoid contact with water.
7 7.3.1 Accidental contact with water Your Accu-Chek Spirit Combo insulin pump is IPX8 waterproof when leaving the factory site. However hair-line cracks could appear during use. Therefore we may only guarantee protection against brief accidental water contact such as: jj Rain jj Water splashes while you are cycling, jogging or hiking jj Accidental immersion in the sink, washbasin or bath What to do after any water contact Put your pump into STOP mode, disconnect the pump from your body, and inspect it.
7.4 Repair of your pump c CAUTION Do not perform any servicing or repair on your pump. Do not use any lubricants on the pump mechanism. If you have questions, contact your Accu-Chek Customer Care (details on inside back cover). If you have problems with your pump, contact your Accu-Chek Customer Care (details on inside back cover). Your Accu-Chek Customer Care can answer many questions and resolve many problems over the telephone. You may be requested to return your pump to Roche Diabetes Care, Inc.
7 7.5 Maintaining your pump 7.5.1 Cleaning your pump 7.5.2 Batteries The best time to clean your pump is when you change the cartridge. Use a soft cloth to clean the outside of the pump. If necessary, use a clean cloth with alcohol (isopropanol or ethanol). If these measures are not successful, contact your Accu-Chek Customer Care (details on inside back cover) for more instructions. Also see section 7.3.1 Accidental contact with water.
7.6 Storing your pump c CAUTION When your pump will not be in use for a long period of time, it must be properly stored to prevent any subsequent malfunction. To store your pump, place it in STOP mode, then: jj Remove the battery to preserve the battery life jj Remove the cartridge jj Insert the battery cover jj Store your pump in its packaging Storage conditions Temperature 41 °F to 113 °F (+5 °C to +45 °C) Air humidity 5 to 85 % relative air humidity Barometric pressure 500 to 1060 mbar 7.
8 8 Warnings and errors A safety system monitors and controls the function of your Accu-Chek Spirit Combo insulin pump. This safety system performs more than 9 million safety checks every day. If it detects a change from the pump’s normal state, it will trigger a warning or an error message. Beeps, vibrations, and messages on the pump screen indicate the cause of a warning or error. Warnings and errors are the only way you can be quickly notified of any changes in your pump.
8.1 Confirming a warning or error When you confirm: W1: CARTRIDGE LOW E1: CARTRIDGE EMPTY W2: BATTERY LOW E2: BATTERY EMPTY W5: PUMP TIMER (“Backup” pumps only) E5: END OF OPERATION (“Backup” pumps only) the symbol for that warning or error stays in the RUN screen or STOP screen as a reminder. Battery low symbol Pump timer symbol Cartridge low symbol Key Lock symbol When a warning or an error occurs: jj Press f to turn off the beeps and vibrations. The warning or error code stays on the display.
8 8.2 List of warnings w WARNING jj Press f twice to snooze and to confirm the warning. Change the cartridge before it is empty. After a warning occurs, your Accu-Chek Spirit Combo insulin pump may be in STOP mode and insulin delivery may be interrupted. In order to maintain insulin delivery, you must act immediately according to the instructions given for each error code, or put your Accu-Chek Spirit Combo insulin pump in RUN mode to continue the insulin delivery.
Warning W2: BATTERY LOW The battery power is low. Be prepared for a battery change as soon as possible. The battery low symbol appears in the RUN or STOP screen as a reminder until you change the battery. Warning W3: REVIEW TIME The pump has been without power for more than one hour. The pump settings and history data are saved in memory regardless of power loss. However, it may be necessary to set the time and date again. jj Press f twice to snooze and to confirm the warning.
8 Warning W4: CALL FOR UPDATE Your pump has been in use for 6 years now. You may want to consider updating to a new product. Warning W5: PUMP TIMER (“Backup” pumps only) Your pump’s operating time will expire soon. When the warning W5: PUMP TIMER occurs, the pump will display the symbol to remind you to check the timer. jj Press f twice to snooze and to confirm the warning. jj Press f twice to snooze and to confirm the warning. jj Put your pump in RUN mode if necessary.
jj Move to the PUMP TIMER screen. The days until the pump timer expires are shown. Warning W6: TBR CANCELLED (Temporary Basal Rate Cancelled) A temporary increase or decrease in the basal rate has been cancelled. jj Press f twice snooze and to confirm the warning. When the PUMP TIMER reaches zero, the pump will change to STOP mode and will no longer operate. The error, E5: END OF OPERATION, will appear on the display.
8 Warning W7: TBR OVER (Temporary Basal Rate Over) A Temporary Basal Rate has ended. The original basal rate (100 %) will resume automatically once the warning has occurred. Warning W8: BOLUS CANCELLED A bolus was cancelled during the start delay or after delivery began. jj Press f twice to snooze and to confirm the warning. jj Press f twice to snooze and confirm the warning. jj Decide whether a further Temporary Basal Rate change is required. If necessary, program a new Temporary Basal Rate.
Warning W9: LOANTIME WARNING (loan pumps only) The pump is coming to the end of its loan period. In the MY DATA menu, check the remaining loan time in the PUMP TIMER menu. Make sure that you arrange for the replacement of the pump within the scheduled loan time. Warning W10: BLUETOOTH FAULT You need to re-do the pairing procedure for the Accu-Chek Spirit Combo insulin pump and Meter. See section 6.3 Pairing your pump with the Meter. jj Press f twice to snooze and to confirm the warning.
8 8.3 List of errors w WARNING After the occurrence of an error, your Accu-Chek Spirit Combo insulin pump is in STOP mode and insulin delivery is interrupted. In order to maintain insulin delivery, you must act immediately according to the instructions given for each error. jj Reconnect the infusion set or insert a new one. jj Put your pump in RUN mode. See section 3.5 Changing the cartridge and infusion set. Error E2: BATTERY EMPTY The battery is empty. You must replace it immediately.
jj Press f twice to snooze and to confirm the error. Error E3: AUTOMATIC OFF Automatic Off is a safety feature that stops insulin delivery and triggers the error E3: AUTOMATIC OFF if no keys are pressed within a programmed time period in RUN mode. jj Press f twice to snooze and to confirm the error. jj Replace the battery. jj Put your pump in RUN mode. Note Your pump stores the settings you saved before the battery power ran out.
8 Error E4: OCCLUSION w WARNING If the error E4: OCCLUSION (blockage) occurs, follow the steps listed below: jj Press f twice to turn off and to confirm the error. If the error E4: OCCLUSION occurs, immediately check your blood glucose level, and then check again about 2 hours later, as insulin delivery has been interrupted. If your blood glucose level is high, take appropriate action according to your doctor’s or healthcare team’s instructions. Insulin was not delivered.
In rare cases, the cartridge itself can be the cause of the occlusion. If the error E4: OCCLUSION occurs again, you must change the cartridge. Follow the steps listed below: jj Press f twice to turn off and to confirm the error. jj Disconnect or remove the infusion set from your infusion site. jj Change the cartridge and prime the infusion set, as explained in chapter 2. jj Reconnect or insert a new infusion set at your infusion site. jj Put your pump in RUN mode.
8 Error E5: END OF OPERATION (“Backup” pumps only) The pump timer of your Backup pump has reached zero. The pump changes to STOP mode and will no longer operate. The error E5: END OF OPERATION appears on the display. Before this error occurs, the warning W5: PUMP TIMER will remind you to replace your pump soon. If necessary, use the alternative therapy plan provided by your doctor or healthcare team.
Error E6: MECHANICAL ERROR A mechanical error has been discovered during a routine automatic system check and insulin delivery has stopped. jj Press f twice to snooze and to confirm the error. jj Remove or disconnect the infusion set from your infusion site. jj Remove the cartridge, adapter, infusion set, and battery from your pump. Insert a new battery. jj It is essential that you rewind the piston rod. Install a new cartridge and infusion set. (See section 2.7 Inserting the cartridge).
8 jj Remove or disconnect the infusion set from your infusion site. Error E8: POWER INTERRUPT A power interrupt error occurs when you insert a new battery without first placing the pump in STOP mode. See section 2.2 Inserting the battery for instructions on how to change the battery. The error can also occur if the pump has been dropped. In this case, see section 7.2.1 What to do if you drop your pump. jj Replace the battery in the pump (See section 2.2 Inserting the battery). jj Prime the infusion set.
Error E9: END OF OPERATION (loan pumps only) Your pump timer has reached zero. The pump changes to STOP mode and will no longer operate. The error E9: END OF OPERATION appears on the display. Before this error occurs, the warning W9: LOANTIME WARNING will remind you to replace your pump soon. If necessary, use the alternative therapy plan provided by your doctor or healthcare team. jj Press f twice to snooze and to confirm the error.
8 jj Prime the infusion set. jj Reconnect the infusion set at your infusion site. jj Put your pump into RUN mode. jj If the error E10: CARTRIDGE ERROR occurs during the rewinding of the piston rod, insert a new battery in the pump and repeat the procedure. See sections 3.5 Changing the cartridge and infusion set and 2.8 Priming the infusion set. w WARNING Never prime an infusion set that is connected to your body. You risk uncontrolled insulin delivery into your body.
Error E12: DATA INTERRUPTED c jj Press f twice to snooze and to confirm the error. CAUTION If infrared data transfer between your pump and a compatible device is disrupted in any way, the configuration may be incomplete and the error E12: DATA INTERRUPTED will occur. The data transfer must be successfully completed before you can put your Accu-Chek Spirit Combo insulin pump into RUN mode. Data transfer between your pump and the computer was interrupted before it was completed.
8 Error E13: LANGUAGE ERROR The language setting needs to be checked. jj Press f twice to snooze and to confirm the error. jj Follow the steps in section 5.6 Pump settings to change the language. jj Put your pump in RUN mode. 163 man_05504929001_H_en-us.indb 163 01.06.
8.4 List of reminders Reminder R1: REMINDER A reminder has been programmed on the pump. jj Press f twice to snooze and to confirm the reminder. jj If necessary, put your pump in RUN mode. Note If you have set the reminder occurrence to EVERY DAY, the same reminder occurs every 24 hours. Turn the reminder function OFF if you do not want the alarm to go off again at that same time every day. See section 5.9 Setting a reminder. 164 man_05504929001_H_en-us.indb 164 01.06.
9 9 Troubleshooting This chapter describes problems that may occur when using your Accu-Chek Spirit Combo insulin pump. Any problems that generate a warning or error are described in chapter 8. Note The solutions provided in this chapter will normally enable you to resolve the problem and continue with your pump therapy.
9.1 Therapy-related issues Many factors – such as alcohol consumption, medication, decreased activity, illness and stress – can affect your blood glucose level. Contact your doctor or healthcare team for advice on how to manage these, or any other, therapy-related issues. Problem Recommended Action Individual characters, numbers, or symbols on the display are shown incompletely or not at all. Contact your Accu-Chek Customer Care (details on inside back cover).
9 Problem Recommended Action There are air bubbles in the cartridge and /or infusion set. Check your blood glucose level. In the cartridge: Disconnect the infusion set from the headset and re-prime the infusion set. If the air bubbles remain, replace the cartridge. Always fill the cartridge with insulin that is at room temperature. In the infusion set: Disconnect from the headset and prime your infusion set. Reconnect the headset and ensure that all connections are tight and secure.
Problem Recommended Action There is a leak in the system. Check your blood glucose level. Check for leaking insulin at all the connection points and on the skin. Change the infusion set, the infusion site, the cartridge and the adapter. There is an occlusion (blockage) in the system. Check your blood glucose level. Follow the instructions in chapter 8 Error E4: OCCLUSION. Priming was not completed (E11 or air bubbles in infusion set). Disconnect from the headset and re-prime the infusion set.
A Appendix A: Technical data General Technical Data Maximum dimensions (without adapter) Approx. 82.5 × 56 × 21 mm (3.2 × 2.2 × 0.8 inches) Weight jj empty insulin pump: approx. 80 g (2.8 ounces) jj insulin pump including battery, full plastic cartridge and infusion set: approx. 110 g (3.
General Technical Data Power supply One 1.5 V AA Alkaline (LR6) or Lithium (FR6) battery or one 1.2 V rechargeable NiMH AA (HR6) battery. Batteries should have a minimum capacity of 2500 mAh. Do not use alkaline batteries that do not comply with IEC 60086-1. Do not use lithium batteries that do not comply with IEC 60086-4. Do not use carbon zinc or nickel cadmium (NiCd) batteries. Rechargeable batteries should have a minimum capacity of 2600 mAh.
A General Technical Data Delivery Your Accu-Chek Spirit Combo insulin pump delivers insulin according to the programmed hourly basal rate, 24 hours a day. jj Minimum dose: 1/20 of the hourly basal rate, delivered a maximum of 20 times per hour. jj Test interval: every 3 minutes. Basal rate Min. 0.05 U / h, max. 25 U / h. There are 24 hourly basal rates adjustable in increments of 0.01 U / h (up to 1.00 U / h), 0.05 U / h (up to 10.0 U / h) and 0.1 U / h (up to 25.0 U / h).
General Technical Data Maximum time before the error E4: OCCLUSION** occurs Plastic cartridges: jj at medium basal rate 1.0 U / h: ≤ 2 h jj at minimum basal rate 0.05 U / h: ≤ 24 h Maximum missing volume before the error E4: OCCLUSION** occurs Plastic cartridges: ≤ 2.0 U Maximum system occlusion alarm threshold < 400 kPa (4.0 bar) Maximum alarm threshold < 400 kPa (4.0 bar) Maximum pressure 400 kPa (4.0 bar), for plastic cartridges and infusion sets.
A General Technical Data Infusion sets The Accu-Chek infusion sets with a luer-lock connector (see Appendix C). Data transfer between pump and a PC Infrared interface Safety system The safety concept is based on a control system which consists of two microprocessors (1 main processor and 1 supervisor processor). Whenever a defect or fault occurs in the main processor, it is identified by the supervisor processor.
Technical standards Table 201: Electromagnetic emission Guidance and manufacturer’s declaration – electromagnetic emissions The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Accu-Chek Spirit Combo insulin pump should ensure that it is used in such an environment.
A Table 202: Electrostatic discharge (ESD) and power frequency magnetic fields (all devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of Accu-Chek Spirit Combo insulin pump should ensure that it is used in such an environment.
Immunity test standard IEC 60601 test level * Compliance level Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11 Note < 5 % UT (0.5 cycle) 40 % UT (5 cycles) 70 % UT (25 cycles) < 5 % UT for 5s Electromagnetic environment – guidance Not applicable UT is the A.C. mains voltage prior to application of the test level.
A Table 203: Immunity electromagnetic fields (life-supporting devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Accu-Chek Spirit Combo insulin pump should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a) should be less than the compliance level in each frequency range.
A Table 205: Recommended separation distances (life-supporting devices) Recommended separation distances between portable and mobile RF communications equipment and the Accu-Chek Spirit Combo insulin pump. The Accu-Chek Spirit Combo insulin pump is intended for use in electromagnetic environments in which radiated RF disturbances are controlled.
Note At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
A Accuracy of flow rate for the Accu-Chek 3.15 ml plastic cartridges and the Accu-Chek Spirit 3.15 ml cartridge system Trumpet curve plotted from data after the end of the stabilization period The maximum deviation of the delivered amount (overall mean percentage error of flow rate) for U100 insulin is ≤ ±5 %*, where your Accu-Chek Spirit Combo insulin pump is located ≤ 1 m (3.3 feet) above / below the infusion site.
Start-up graph over the stabilization period The start-up graph shows changes in the flow rate over the stabilization time. real flow target flow 0.012 flow rate (ml / h) 0.010 0.008 0.006 0.004 0.002 0.000 0.01 ml is equivalent to 1 U (U100 insulin) 0 120 240 360 480 600 720 840 960 1080 1200 1320 1440 time (min) 182 man_05504929001_H_en-us.indb 182 01.06.
A Accuracy of flow rate for the Accu-Chek 3.15 ml plastic cartridges and the Accu-Chek Spirit 3.15 ml cartridge system at minimum hourly basal rate of 0,05 U/h Trumpet curve plotted from data after the end of the stabilization period. The maximum deviation of the delivered amount (overall mean percentage error of flow rate) for 100U insulin is ≤ 30%*. The trumpet curve shows the accuracy of the delivery rate in relation to the observation period.
Start-up graph over the stabilization period The start-up graph shows changes in the flow rate over the stabilization time. Bolus For U100 insulin the maximum deviation of a maximum bolus (25 U and 50 U) is ≤ ±5 % and the maximum deviation of a minimum bolus (0.1 U) is ≤ ±30 %*. real flow target flow flow rate (ml / h) 0.002 0.000 0.
B Appendix B: Configuration parameters Typical range available on the pump and standard parameter settings* Maximum parameter range adjustable with the appropriate Accu-Chek PC software 62.5 U / h max. amount: 0–250.0 U / h Default basal rate 0 U/h 0–50 U/h Hourly basal rate increment 0.01 U/h (up to 1.00 U / h), 0.05 U/h (up to 10.0 U / h) and 0.1 U/h (up to 25.0 U / h) 0.0 U/h, 0.05 –25.0 U / h Hourly basal rates 25.0 U / h max. amount: 0–25.
Typical range available on the pump and standard parameter settings* Maximum parameter range adjustable with the appropriate Accu-Chek PC software Bolus Bolus amount per bolus delivery 25.0 U max. amount: 0–25.0 U bolus amount increments for Quick Bolus bolus amount increments for Standard Bolus bolus duration (Extended Bolus, Multiwave Bolus) bolus duration increments 0.5 U 0.1 U max. 12 h 15 min 0.1 U, 0.2 U, 0.5 U, 1.0 U or 2.0 U 15 min–50 h 15 min, 30 min, 1 h Prime volume 25.0 U max.
B Typical range available on the pump and standard parameter settings* Battery type AA (LR6) ALKALINE, AA (FR6) LITHIUM or AA (HR6) NiMH rechargeable battery Key Lock On or Off Automatic off On (1–24 h) or Off (0 h) Reminder On or Off If On: occurs once or every day Time format European (24 h) or American (12 h, am / pm) Date format European (dd.mm.
Appendix C: Sterile products and accessories Cartridges Accu-Chek infusion sets Name Comments Name Comments Accu-Chek Spirit 3.15 ml cartridge system Accu-Chek 3.15 ml plastic cartridge Plastic cartridges are single-use items only. Do not re-use cartridges. Refer to the instructions for use of the insulin you are using for information on the acceptable temperature range for storage and handling.
C Accessories Name Comments Name Adapter Battery cover Adapter and battery cover are part of the Accu-Chek Spirit Combo service pack and the Accu-Chek Spirit Combo service pack small. Replace your adapter and battery cover every 2 months. For battery lifetime see p. 170 Batteries Lifetime of battery One 1.5 V, AA alkaline (LR6) battery compliant with IEC 60086-1 or one lithium (FR6) battery compliant with IEC 60086-4.
Name Comments Name Comments Rechargeable batteries One 1.5 V, AA alkaline (LR06) battery compliant with IEC 60086-1 or one lithium (FR06) battery compliant with IEC 60086-4. The Accu-Chek Spirit Combo insulin pump was successfully tested with a Varta Power One alkaline LR06, AA, 1.5 V battery which complies with IEC 60086-1 and with an Energizer Ultimate Lithium FR06, AA, 1.5 V battery which complies with IEC 60086-4. The battery should have a minimum capacity of 2500 mAh. For battery lifetime see p.
D Appendix D: Abbreviations Abbreviation Meaning Abbreviation Meaning approx. Approximately sec. Seconds BRP Basal rate profile TBR Temporary Basal Rate h Hour (s) U IEC International Electrotechnical Commission International Units in context with biological effectiveness of a certain insulin amount IR Infrared U/h Amount of International Units of insulin delivered per hour kPa Kilopascal U100 LCD Liquid Crystal Display LED Light Emitting Diode for infrared communication with e.
Appendix E: Beeps and melodies Acoustic Signals All of the functions of the Accu-Chek Spirit Combo insulin pump are supported by acoustic signals. The acoustic signals are beeps. Sound Function Duration for very short sound = 31.25 ms ±20 % Duration for short sound = 62.5 ms ±20 % Duration for medium sound = 93.75 ms ±20 % Duration for long sound = 125.0 ms ±20 % Duration for short pause = 125.0 ms ±20 % Duration for medium pause = 218.75 ms ±20 % Duration for long pause = 500.
E Sound Function BASE STATE RUN (KEYS UNLOCKED) Frequency: 2789 Hz ±5 % Duration: Short sound, short pause, short sound, short pause, short sound BASE STATE RUN (KEYS LOCKED) Frequency: 2763 Hz ±5 % Duration: Short sound, short pause, short sound, short pause, short sound BASE STATE STOP (KEYS UNLOCKED) Frequency: 2789 Hz ±5 % Duration: Long sound, short pause, long sound, short pause, long sound BASE STATE STOP (KEYS LOCKED) Frequency: 2763 Hz ±5 % Duration: Long sound, short pause, long sound, short
Sound Function + + 50 U < CARTRIDGE CONTENT ≤100 U Frequency: f1 = 2090 Hz ±5 %, f2 = 2486 Hz ±5 %, f3 = 2789 Hz ±5 % Duration: f1 short sound, f2 short sound, long pause, f3 medium sound 100 U < CARTRIDGE CONTENT Frequency: f1 = 2090 Hz ±5 %, f2 = 2486 Hz ±5 %, f3 = 2789 Hz ±5 % Duration: f1 short sound, f2 short sound, long pause, f3 long sound Sound Function COPY BASAL RATE Frequency: 2486 Hz ±5 %, 3131 Hz ±5 %, 2486 Hz ±5 % Duration: 3 × short sound TEMPORARY BASAL RATE ACTIVE Frequency: 2789
E Sound Function Reminder (REPEATING SEQUENCE) Frequency: f1 = 1043 Hz ±5 %, f2 = 1850 Hz ±5 % Duration: f1 medium sound, short pause, f2 medium sound, short pause, f1 medium sound, medium pause, f2 medium sound Repeating Interval: 3000.0 ms ±20 % WARNING (REPEATING SEQUENCE) Frequency: f1 = 1043 Hz ±5 %, f2 = 1850 Hz ±5 % Duration: f1 medium sound, short pause, f2 medium sound, short pause, f1 medium sound, medium pause, f2 medium sound, short pause, f2 medium sound Repeating Interval: 3000.
Sound Function OK KEY PRESSED Frequency: 2789 Hz ±5 % Duration: Short sound + + + + + CHANGED TO BASE STATE RUN BY OK KEY (KEYS UNLOCKED) Sequence: A12, long pause, A14 CHANGED TO BASE STATE RUN BY OK KEY (KEYS LOCKED) Sequence: A12, long pause, A15 CHANGED TO BASE STATE STOP BY OK KEY (KEYS UNLOCKED) Sequence: A12, long pause, A16 CHANGED TO BASE STATE STOP BY OK KEY (KEYS LOCKED) Sequence: A12, long pause, A17 Sound Function INITIAL POINT (SUBMENU, VALUE) Frequency: 2820 Hz ±5 % Duration: Short s
E Tactile Signals Dedicated functions of the Accu-Chek Spirit Combo insulin pump are supported by tactile signals additionally. The tactile signals are vibrations which are generated by a vibra motor. Signal Function SHORT VIBRATION Duration short vibration = 109.375 ms ±5 % MEDIUM VIBRATION Duration medium vibration = 203.125 ms ±5 % LONG VIBRATION Duration long vibration = 281.25 ms ±5 % Signal Function WARNING AND REMINDER (REPEATING SEQUENCE) Duration vibration = 1062.5 ms ±5 % Duration pause = 2125.
Appendix F: Symbols Display Symbols Icon Meaning Icon Meaning Basal Lock OFF Bluetooth ® ON Basal Lock ON Bluetooth ® Settings Basal Rate Bluetooth ® in Remote control mode Basal Rate Total Beep Test Battery Empty Cartridge Empty Battery Low Cartridge Full Beep Volume Cartridge Low Bluetooth ® OFF OK 198 man_05504929001_H_en-us.indb 198 01.06.
F Icon Meaning Icon Meaning Clock Key Lock ON Data Transfer menu Pump timer (Call for update) Data Transfer (to start screen) Menu Settings Data Transfer running Multiwave Bolus Date Multiwave Bolus Immediate Date Format EU My Data Date Format US Pairing Failed Display contrast Pairing Successful Extended Bolus Priming Key Lock OFF Progress Bar 199 man_05504929001_H_en-us.indb 199 01.06.
Icon Meaning Icon Meaning Pump Settings Stop Reminder Total Reminder Everyday Temporary Basal Rate Reminder OFF Therapy Settings Reminder Settings Time and Date Settings Reminder Single Units Display orientation Units per hour Beep Vibrations Beep and Vibration Error Standard Bolus Warning 200 man_05504929001_H_en-us.indb 200 01.06.
F General Symbols Icon Meaning Icon Meaning Consult instructions for use Sterilized using aseptic processing techniques Caution, refer to safety-related notes in the instructions for use accompanying this product.
Icon Meaning Keep away from sunlight Keep dry Do not use if package is damaged Recycling Do not throw away Flammable Admissible humidity range Admissible air pressure range Icon Meaning Bluetooth ® wireless technology Electronic device of type BF according to the standard IEC 60601-1. Protection against electrical shock.
F Icon Meaning Symbol for protection against the effect of temporary immersion in water (up to 60 minutes and 2.5 meters [8 feet]), according to IEC 60529. Admissible temperature range during operation Warning against device use in electromagnetic or high electrical field or environments 203 man_05504929001_H_en-us.indb 203 01.06.
Appendix G: Warranty and Declaration of Conformity Limited Four-Year Warranty Declaration of Conformity Roche Diabetes Care, Inc. warrants the ACCU-CHEK® Spirit Combo insulin pump (“insulin pump”) against defects in materials and workmanship for a period of four (4) years from the date of purchase. Proof of purchase date may be required. This warranty does not include supplies and accessories, including but not limited to, cartridges, batteries, or infusion sets.
F This warranty is valid only if the insulin pump is used in accordance with the user instructions. This warranty will not apply: 1. If damage results from changes or modifications made to the insulin pump by the user or third persons after the date of manufacture; 2. If damage results from service or repairs performed by any person or entity other than Roche Diabetes Care, Inc. 3. If damage results from a force majeure or other event beyond the control of Roche Diabetes Care, Inc.; or 4.
Glossary Adapter The adapter connects the cartridge and infusion set. It has 2 seals and forms an efficient seal for the cartridge compartment of your Accu-Chek Spirit Combo insulin pump. The 2 small vents on the adapter allow the equalization air pressure. Automatic Off Automatic Off is a safety feature that stops insulin delivery and triggers an error if no keys are pressed within a programmed time period in RUN mode. See the entry in chapter 5 Persona lizing your pump.
Carrying system A wide variety of carrying systems made of different materials are specially designed to suit your individual needs while wearing your Accu-Chek Spirit Combo insulin pump. Cartridge The insulin reservoir of your Accu-Chek Spirit Combo insulin pump. It holds 3.15 ml (315 U) of rapid-acting insulin. Cartridge compartment The chamber in your Accu-Chek Spirit Combo insulin pump for the cartridge.
Insulin (rapid-acting) A type of insulin created using recombinant DNA technology. The onset time of insulin analogue is shorter than the onset time of regular insulin. IPX8 according to IEC 60529 Protection against the effects of temporary immersion in water. Ingress of water in quantities causing damage is not possible when the device is temporarily immersed in water under standardized conditions (maximal 60 minutes a day and 2.5 meters [8 feet]).
RUN screen The RUN screen is the starting point for all functions which can be accessed while your Accu-Chek Spirit Combo insulin pump delivers insulin. Your Accu-Chek Spirit Combo insulin pump displays the RUN screen during normal use when no programming is being performed. The time, current hourly basal rate, selected basal rate profile and all currently activated functions appear on the RUN screen.
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Index A Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Adapter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14, 144, 189 ADVANCED user menu . . . . . . . . . . . . . . . . . . . . . . . . . . 94, 114 Air bubbles. . . . . . . . . . . . . . . . . . . . . . . . . . 14, 36, 43, 44, 167 Aircraft. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
E Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . 177 Electromagnetic radiation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Emergency kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16, 138 Exercise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29, 56, 115 Extended Bolus. . . . . . . . . 71, 78, 79, 81, 82, 92, 171, 186, 199 F Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
R Reminders list of 164, 217 Reminder Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118, 200 Repair of your pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 Rotating display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 4 S Safety system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 Scrolling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 76 Sport . . . . . . . . . . . . . . . .
Warnings and errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 confirming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Wearing your pump carrying systems. . . . . . . . . . . . . . . . . . . . . . . . . 55, 56, 190 in hazardous areas. . . . . . . . . . . . . . . . . . . . .
Quick reference table for errors, warnings and reminders Errors No Error What you have to do No Error What you have to do E1 CARTRIDGE EMPTY Change the cartridge. E6 MECHANICAL ERROR See chapter 8. E2 BATTERY EMPTY Change the battery. E7 ELECTRONIC ERROR See chapter 8. E3 AUTOMATIC OFF Put your Accu-Chek Spirit Combo insulin pump into RUN if necessary. E8 POWER INTERRUPT See chapter 8.
Warnings No Warning What you have to do No Warning What you have to do W1 CARTRIDGE LOW Change cartridge before it is completely empty. W6 TBR CANCELLED W2 BATTERY LOW Replace the battery as soon as possible. W3 REVIEW TIME Set the time and date. Put your Accu-Chek Spirit Combo insulin pump into RUN if necessary. Ensure the cancellation was intended and program a new Temporary Basal Rate if necessary. W4 CALL FOR UPDATE Contact your Accu-Chek Customer Care.
Reminder No Warning What you have to do W9 LOANTIME WARNING In the MY DATA menu, check for the remaining insulin pump loan time under the menu PUMP TIMER. Arrange for replacement of pump within the scheduled pump loan time. W10 BLUETOOTH FAULT No Reminder What you have to do Reminder Put your Accu-Chek Spirit Combo insulin pump into RUN if necessary. Some reminders and warnings are country specific and may never occur on your pump. Re-do pairing procedure for insulin pump and Meter.
Bluetooth ® registration Please note that in Italy and France Bluetooth ® wireless technology is for indoor use only. RAH3 This device complies with part 15 of the FCC Rules. Operation is subject to the following 2 conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
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Your contact for assistance with and/or additional information about your Accu-Chek Spirit Combo insulin pump: In US, distributed by: Roche Diabetes Care, Inc. Indianapolis, IN 46256, USA Toll Free: 1-800-280-7801 ACCU-CHEK Customer Care Service Center: 1-800-688-4578 www.accu-chek.com man_05504929001_H_en-us.indb 3 01.06.
ACCU-CHEK, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK TENDERLINK, ACCU-CHEK FLEXLINK, ACCU-CHEK RAPID-D and ULTRAFLEX are trademarks of Roche. EN-US: 05504929001/H Last update: 2016-04 The Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Roche is under license. Other trademarks and trade names are those of their respective owners. © 2016 Roche Diabetes Care In US, distributed by: Roche Diabetes Care, Inc.
